Donor Breast Milk and Breastfeeding Rates

August 30, 2022 updated by: Kara L. Calkins, MD, University of California, Los Angeles

Use of Human Milk-Based Diet in the Late Preterm and Term Infant in the Neonatal Intensive Care Unit: A Pilot Randomized Controlled Trial

The purpose of this pilot study is to determine if a randomized controlled study comparing a human milk diet versus a formula supplemented diet in late preterm and term infants in the neonatal intensive care unit (NICU) is feasible.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In late preterm infants and term neonates in the NICU whose mothers intend to breastfeed, this pilot study seeks to 1. determine study feasibility (consent rate, study completion rate, and rate of adherence to study diet), and 2. determine whether a dietary supplementation with donor human milk vs. formula improves: a. the percentage of maternal milk consumption at time of discharge from the NICU, or 7 days of age, whichever is later, b. breastfeeding rates and intent to breastfeed at 6-8 weeks chronological age, and c. breast feeding duration.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • Ronald Reagan UCLA Medical Center
      • Los Angeles, California, United States, 90404
        • Santa Monica-UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 days (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gestational age >34 weeks and 0 days
  • Mother's intent to breast feed
  • NICU admission which is predicted to be at least 72 hours from time of admission

Exclusion Criteria:

  • Confirmed genetic disorders and syndromes or other disorders known to affect growth and ability to bottle feed or breast feed (i.e., Trisomies)
  • Common neonatal congenital anomalies (cardiac disease, congenital gastrointestinal disorders, etc)
  • Commonly accepted contraindications for breast feeding (HIV, galactosemia, herpes lesions on the breast, maternal use of drugs that are considered contraindicated with breast feeding including marijuana)
  • Infant admitted to the intensive care unit who is receiving invasive respiratory support (intubation) and/or ionotropic medications
  • Any infant whose care is considered futile by the primary medical team

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Exclusively Human Milk Diet
This group will receive human milk only. If the mother is not producing enough breast milk, this group will receive donor milk supplementation.
Other: Donor Breast Milk
Donor breast milk will be given to the newborn if supplementation is required
NO_INTERVENTION: Formula-based Diet
If the mother is not producing enough breast milk, this group will receive formula supplementation (the standard of care).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study Feasibility_1
Time Frame: 6-8 weeks chronological age
Feasibility will be evaluated by: consent rate
6-8 weeks chronological age
Study Feasibility_2
Time Frame: 6-8 weeks chronological age
Feasibility will be evaluated by: study completion rate
6-8 weeks chronological age
Study Feasibility_3
Time Frame: 6-8 weeks chronological age
Feasibility will be evaluated by: rate of adherence to the study diet.
6-8 weeks chronological age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Human Milk Consumption at Discharge
Time Frame: at the time of NICU discharge or 7 days of age, whichever is later
Maternal milk/total milk (percent) consumed by the neonate over 48 hours
at the time of NICU discharge or 7 days of age, whichever is later
Percentage of Human Milk Consumption After Discharge
Time Frame: 6-8 weeks chronological age
Maternal milk/total milk (percent) consumed by the infant over 48 hours
6-8 weeks chronological age
Breastfeeding duration
Time Frame: 6-8 weeks chronological age
time infant received breastmilk since birth
6-8 weeks chronological age
Intent to Breastfeed
Time Frame: 6-8 weeks chronological age
Mother's desire to continue to breastfeed: specifically assessed by asking the mother if she plans to exclusively breastfeed or not. Answers will be recorded as yes or no.
6-8 weeks chronological age
Growth: Weight
Time Frame: 6-8 weeks chronological age
Weight in kilograms reported as a z-score
6-8 weeks chronological age
Growth: Height
Time Frame: 6-8 weeks chronological age
height in centimeters reported as a z-score
6-8 weeks chronological age
Growth: Head Circumference
Time Frame: 6-8 weeks chronological age
head circumference in centimeters reported as a z-score
6-8 weeks chronological age

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intestinal Microbiome: microbial profiling (genus level)
Time Frame: 7 days of age
Microbial profiling (genus level) will be investigated by sequencing of the V4 region of the 16S ribosomal ribonucleic acid gene
7 days of age
Intestinal Microbiome: alpha diversity (Chao1)
Time Frame: 7 days of age
Alpha diversity (Chao1) will be investigated by sequencing of the V4 region of the 16S ribosomal ribonucleic acid gene
7 days of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2020

Primary Completion (ACTUAL)

June 26, 2022

Study Completion (ACTUAL)

August 15, 2022

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

September 26, 2020

First Posted (ACTUAL)

October 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 1, 2022

Last Update Submitted That Met QC Criteria

August 30, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 19-002179

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no current plan to make IPD available for other research given this is a small pilot feasibility study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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